Currently, there are no approved medications for the prevention and treatment of radiation-induced dermatitis, or skin discoloration/burning due to radiation therapy, because there is little evidence to guide treatment. The purpose of the research is to better understand the factors associated with radiation-induced dermatitis and to explore the efficacy of low-dose colchicine in reducing the proportion of patients with radiation-induced dermatitis who undergo radiation treatment for head and neck cancer. If you take part in the research, you will be asked to take 0.6 mg once a day by mouth. The participants time in the study will take less than a minute a day to take the pill and 20 minutes to complete survey questions during follow-up visits.
A phase I study for evaluating the safety of oral colchicine in preventing and treating radiation-induced dermatitis among head and neck cancer patients who will receive RT for HNC. Prior to receiving RT, each subject will be receiving either the standard of care or low-dose oral colchicine (No randomization). There will be a comparison of the proportion of radiation-induced dermatitis in the two study arms. The individuals in the standard of care arm will receive a placebo colchicine pill once a day. Those who are in the experimental arm will receive 0.6 mg of oral colchicine once a day. The primary endpoint is the safety and tolerability of oral colchicine. The proportions of grade 2-4 radiation-induced dermatitis at the end of Radiation therapy (RT) and at the first follow-up three-four weeks post-treatment in these two study arms are the secondary study endpoints. In addition, pain, erythema, and health-related quality-of-life will be evaluated. The study subjects will receive radiation therapy (RT) as scheduled and will meet with their clinicians for their follow-up visits.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The standard of care arm will receive a placebo colchicine pill once a day
RWJBarnabas Health - Cooperman Barnabas
Livingston, New Jersey, United States
RECRUITINGRobert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
RECRUITINGRutgers, The State University of New Jersey Board Contact:
New Brunswick, New Jersey, United States
RECRUITINGPain - Visual Analogue Scale (VAS)
Pain (within radiation fields): assessed before radiotherapy, weekly during radiotherapy, and at the end of treatment with the visual analogue scale (VAS) (from 0 = no pain to 100 = maximum pain)
Time frame: 10 weeks
Erythema - Common Toxicity Criteria for Adverse Events (CTCAE)
The National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) scale defines acute skin reactions to radiation occurring within the 90 days after therapy. Grade 1: faint erythema or dry desquamation. Arising within the first two to four weeks of treatment, these reactions cause skin redness, warmth, and a rash-like appearance. The patient may complain that their skin feels tight or sensitive. Grade 2: moderate to brisk erythema; patchy, moist desquamation usually confined to skin folds or creases. Moderate edema, dryness, pruritus, and flaking of skin layers (dry desquamation) also may occur. Grade 3: moist desquamation in areas other than creases and skinfolds. Bleeding may arise from minor trauma, such as abrasion. Grade 4: life-threatening consequences, such as full-thickness skin ulcers, necrosis, and spontaneous bleeding. Grade 5: death.
Time frame: 10 weeks
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